Attain Ability Plus MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 161
- Deaths reported
- 0
- Injuries reported
- 99
- Recalls
- 0
We found 4 models of Attain Ability Plus MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 161 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 10, 2026 — classified as 99 injuries, 62 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (51 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Attain Ability Plus MRI SureScan problems
Device problems
- High Capture Threshold51
- Adverse Event Without Identified Device or Use Problem42
- Device Dislodged or Dislocated24
- Failure to Capture23
- Capturing Problem12
- High impedance9
- Appropriate Device Problem Term/Code Not Available8
- Pacing Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions71
- No Known Impact Or Consequence To Patient32
- Unspecified Infection19
- Muscle Stimulation12
- Undesired Nerve Stimulation11
- Device Overstimulation of Tissue9
- No Consequences Or Impact To Patient3
- Endocarditis2
Attain Ability Plus MRI SureScan models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Ability™ Plus MRI SureScan™ 429688Drug eluting permanent left ventricular (lv) pacemaker electrode80 reports
- Attain Ability™ Plus MRI SureScan™ 429688permanent pacemaker Electrode52 reports
- Attain Ability™ Plus MRI SureScan™ 429678Drug eluting permanent left ventricular (lv) pacemaker electrode16 reports
- Attain Ability™ Plus MRI SureScan™ 429678Drug eluting permanent left ventricular (lv) pacemaker electrode13 reports
Recent Attain Ability Plus MRI SureScan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026High impedance
It was reported that the Left Ventricular (LV) lead exhibited high, out-of-range, undefined impedance. The lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715093 ↗InjuryJul 27, 2026Extracardiac stimulation
It was reported that the patient experienced intermittent diaphragmatic stimulation and phrenic nerve stimulation from the Left Ventricular (LV) lead. The lead was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50037461 ↗MalfunctionApr 28, 2026Low impedance
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED A WARNING FOR UNDEFINED LOW PACING IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019726 ↗MalfunctionApr 17, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY THE PATIENT "NEEDS AN MAGNETIC RESONANCE IMAGING (MRI) AND MEDTRONIC IS SAYING NO BECAUSE OF ONE OF MY LEADS." THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911386 ↗InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO AN INFECTION WITH REDNESS AND SWELLING AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Erythema; Swelling/ Edema; Unspecified Infection
MAUDE report 24581739 ↗MalfunctionFeb 6, 2026High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283125 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOTH DIAPHRAGMATIC AND PHRENIC NERVE STIMULATION POST IMPLANT PROCEDURE. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Overstimulation of Tissue; Undesired Nerve Stimulation
MAUDE report 24215049 ↗InjuryNov 13, 2025Intermittent Capture; High Capture Threshold; Intermittent Capture; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND INTERMITTENT LV CAPTURE. THE RA AND LV LEADS WERE BOTH EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543049 ↗InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED POCKET DEHISCENCE. IT WAS ALSO REPORTED THAT THE RV LEAD WAS PARTIALLY EXPLANTED DUE TO DURING EXTRACTION EXTENSIVE CALCIFICATION AT SUPERIOR VENA CAVA (SVC) BRACHIOCEPHALIC JUNCTION. AFTER SEVERAL ATTEMPTS TO REMOVE THE RV LEAD, THE LEAD BROKE. THE RV LEAD WAS PULLED BACK INTO THE POCKET AND CUT. IT WAS ALSO REPORTED THAT THERE WAS MODERATE TO SEVERE TR (TRICUSPID REGURGITATION).
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 23501157 ↗InjuryOct 28, 2025Capturing Problem; Capturing Problem
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23403924 ↗MalfunctionOct 23, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POTENTIAL ATRIAL UNDER SENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) EVENT(S) AT TIMES AS WELL AS UNDERSENSING ON ATRIAL LEAD APPEARS TO RESULT IN INAPPROPRIATE ATRIAL PACING. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED POSSIBLE LOSS OF CAPTURE NOTED ON THE VENTRICULAR LEAD ON STORED AND CURRENT ELECTROGRAMS (EGM). IN ADDITION HIGH RIGHT VENTRICULAR THRESHOLDS OCCURRED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373451 ↗InjuryOct 15, 2025Over-Sensing; Pacing Problem; High Capture Threshold; Over-Sensing; Pacing Problem; High Capture Threshold
IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SENSITIVITY WAS READJUSTED AND THE RV CAPTURE THRESHOLD IS IMPROVING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290808 ↗InjurySep 15, 2025High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE DEPLETION. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLDS. THE DEVICE WAS REMOVED AND REPLACED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23049005 ↗MalfunctionAug 19, 2025High Capture Threshold; High Capture Threshold
IT WAS FURTHER REPORTED THAT THE LV LEAD CONTINUED TO EXHIBIT HIGH THRESHOLDS. IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED UND ERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. THE LV AND RA LEADS REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843097 ↗MalfunctionAug 14, 2025High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING, AND THERE WERE HIGH RIGHT VENTRICULAR (RV) CAPTURE THRESHOLDS OBSERVED. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS PACING FROM THE DEVICE'S RV PORT. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804559 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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